Consumer Medicine Information (CMI) summary
The
full CMI on the next page has more details. If you are worried about using this medicine,
speak to your doctor or pharmacist.
1. Why am I using REVATIO?
REVATIO contains the active ingredient sildenafil (present as sildenafil citrate).
REVATIO is used to treat pulmonary arterial hypertension (high blood pressure in the
blood vessels in the lungs). REVATIO lowers the blood pressure by relaxing these vessels.
For more information, see Section
1. Why am I using REVATIO? in the full CMI.
2. What should I know before I use REVATIO?
Do not use if you have ever had an allergic reaction to sildenafil or any of the ingredients
listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines,
or are pregnant or plan to become pregnant or are breastfeeding.
3. What if I am taking other medicines?
Some medicines may interfere with REVATIO and affect how it works.
4. How do I use REVATIO?
Tablet: The usual dose is one 20 mg tablet taken three times a day (taken 6-8 hours
apart).
Solution for Injection: The usual dose of is 10 mg three times a day (given 6-8 hours
apart) given by a doctor or trained nurse.
REVATIO is not for use in children under 18 years of age.
5. What should I know while using REVATIO?
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Things you should do
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Remind any doctor, dentist or pharmacist you visit that you are using REVATIO.
You must stop treatment with REVATIO if you have sudden vision problems including
blurred, decreased or distorted vision, objects appear smaller or further away than
they are, changes to colour vision, loss of eyesight in one or both eyes, or have
an erection that lasts more than 4 hours. Seek medical attention urgently.
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Things you should not do
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Do not use drugs containing amyl nitrite (sometimes called "poppers") while you are
on REVATIO.
If you get an angina attack do not take nitrate medicines to relieve the pain but
tell your doctor immediately.
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Driving or using machines
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If you experience changes in vision, or dizziness, when on REVATIO, you should not
drive or operate machinery.
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Drinking alcohol
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You may feel lightheaded if you drink alcohol while you are using REVATIO.
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Looking after your medicine
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Keep REVATIO tablets where children cannot reach it.
Keep REVATIO tablets in a cool, dry place where the temperature stays below 30°C.
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6. Are there any side effects?
Tell your doctor or pharmacist if you notice headache dizziness, flushing, indigestion,
stuffy nose, muscle aches, back or limb pain, rash, diarrhoea or upset stomach, a
numbness or tingling skin sensation, breathlessness or coughing, fever or flu like
symptoms, nose bleeds, difficulty sleeping, hayfever, prolonged erection.
If you have sudden vision problems, lose sight in one or both eyes or experience changes
in vision such as blurring, a blue colour to your vision or a greater awareness of
light while on REVATIO, seek medical attention urgently.
If you experience any loss of hearing, tell your doctor as soon as possible.
Active ingredient(s):
Sildenafil (as citrate)
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using REVATIO. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about using REVATIO.
Where to find information in this leaflet:
1. Why am I using REVATIO?
REVATIO contains the active ingredient sildenafil (present as sildenafil citrate). Sildenafil belongs to a group of medicines called phosphodiesterase type 5 (PDE5)
inhibitors.
REVATIO is used to treat pulmonary arterial hypertension (high blood pressure in the
blood vessels in the lungs). Revatio lowers the blood pressure by relaxing these vessels.
Ask your doctor if you have any questions about why this medicine has been prescribed
for you.
Your doctor may have prescribed it for another reason.
2. What should I know before I use REVATIO?
Warnings
Do not use REVATIO if:
you are taking nitrite or nitrate medications.
you are being treated for angina (chest pain), or other heart conditions with medicines
called nitrates.
These are available in multiple dosage forms, such as tablets, patches, sprays and
injections. Active ingredients in nitrate medicines include, but not limited to:
glyceryl trinitrate (also called nitroglycerin)
isosorbide mononitrate, isosorbide dinitrate
nicorandil
sodium nitroprusside.
you are taking guanylate cyclase stimulators (GCS), such as riociguat.
GCS is a type of medicine used to treat high blood pressure in the blood vessels in
the lungs caused by blood clots in the lungs (chronic thromboembolic pulmonary hypertension,
CTEPH) or narrowing of the vessels that carry blood from the heart to the lungs (pulmonary
arterial hypertension or PAH).
you have suffered a heart attack or stroke in the last 6 months.
you have severe liver problems.
you have blood pressure that is unusually low and is not effectively treated.
you have an eye disease called retinitis pigmentosa.
you have sudden vision problems including loss of vision in one or both eyes from
an eye disease called non-arteritic anterior ischaemic optic neuropathy (NAION).
you are taking certain medicines used to treat fungal infections including ketoconazole
and itraconazole.
you are taking ritonavir, a treatment for HIV infection.
you are allergic to sildenafil or similar medicines, or any of the ingredients listed
at the end of this leaflet.
An allergic reaction can include:
hives, itching or skin rash
swelling of the face, lips or tongue which may lead to difficulty swallowing or breathing.
Always check the ingredients to make sure you can use this medicine.
the packaging is torn or shows signs of tampering.
the expiry date on the pack has passed.
Before treatment with REVATIO, check with your doctor if you:
have any allergies to any other medicines or any other substances such as foods, preservatives
or dyes.
have previously had sudden vision problems including blurred, decreased or distorted
vision, objects appear smaller or further away than they are, changes to colour vision,
loss of eyesight in one or both eyes.
have any of the following medical conditions:
heart or blood vessel problems
high blood pressure
diabetes, especially if you also have eye problems
leukaemia (cancer of the blood cells)
multiple myeloma (a cancer of the bone marrow)
any bleeding disorder such as haemophilia or problems with nose bleeds
stomach ulcer
a disease of the blood called sickle cell anaemia
pulmonary veno-occlusive disease (blockage or narrow vein in the lung)
any disease or deformity of your penis
you are receiving any treatment for male erectile dysfunction (impotence) which contains
the same medicine, sildenafil, as REVATIO. There are other tradenames for sildenafil
containing medicines that are not listed here. Other medicines used to treat impotence
include tadalafil and vardenafil.
you are receiving other treatments for your condition
you previously experienced sudden decrease or loss of hearing.
take any medicines for any other condition
During treatment, you may be at risk of developing certain side effects. It is important
you understand these risks and how to monitor for them. See additional information
under Section
6. Are there any side effects?
Pregnancy and breastfeeding
Check with your doctor if you are pregnant or intend to become pregnant.
REVATIO should not be used during pregnancy. Your doctor will discuss the risks with
you.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
You should not breastfeed while being treated with REVATIO.
Use in children
REVATIO is not for use in children under 18 years of age.
3. What if I am taking other medicines?
Tell your doctor or pharmacist if you are taking any other medicines, including any
medicines, vitamins or supplements that you buy without a prescription from your pharmacy,
supermarket or health food shop.
Do not take REVATIO if you are using nitrate medicines for angina.
Do not take REVATIO if you are taking guanylate cyclase stimulators (GCS), such as
riociguat.
Tell your doctor if you are taking any other medicines for pulmonary arterial hypertension.
These medicines include bosentan, epoprostenol or Iloprost.
Some medicines and REVATIO may interfere with each other. These include:
medicines called alpha-blockers. These are used to treat high blood pressure or prostate
problems.
some medicines used to treat epilepsy such as phenytoin, carbamazepine and phenobarbital
St John's wort that may be used to treat mild anxiety
rifampicin used to treat leprosy or tuberculosis
an antibiotic called erythromycin
saquinavir, a medicine used to treat HIV infection
cimetidine for stomach ulcers.
You may need to take different medicines or different amounts of your medicine. Your
doctor or pharmacist can tell you what to do if you are taking any of these medicines.
They also have a more complete list of medicines to be careful with or avoid while
you are being treated with REVATIO.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect REVATIO.
Avoid drinking grapefruit juice. It may increase the level of sildenafil in your blood.
4. How do I take REVATIO?
Take REVATIO tablets exactly as your doctor has prescribed.
Follow all directions given to you by your doctor and pharmacist carefully.
They may differ from the information contained in this leaflet.
How much to take REVATIO
The usual dose is one 20 mg tablet taken three times a day (taken 6-8 hours apart).
When to take REVATIO
Take REVATIO tablets at the same times each day. This will have the best effect and
also help you to remember when to take it. REVATIO tablets can be taken with or without
food.
How to take REVATIO
Swallow the REVATIO tablet whole with a full glass of water.
How long to take REVATIO
You must take REVATIO tablets every day. Continue taking your medicine for as long
as your doctor tells you.
If you forget to take REVATIO
If you miss your dose at the usual time and it is almost time for your next dose,
skip the dose you missed and take your next dose when you are meant to.
Do not take a double dose to make up for the dose you missed.
REVATIO Solution for Injection
REVATIO Solution for Injection is given as an injection into a vein by a doctor or
trained nurse.
Your doctor will determine your dose and how long you need to be given REVATIO Solution
for Injection.
The usual dose of is 10 mg three times a day (given 6-8 hours apart).
REVATIO Solution for Injection is given when you are unable to take REVATIO tablets.
A dose of 10 mg REVATIO Solution for Injection is predicted to provide an effect of
sildenafil equivalent to a 20 mg oral dose.
REVATIO Solution for Injection will be given to you under close medical supervision.
It is unlikely that a dose would be missed.
However, tell your doctor or nurse if you think that a dose has been forgotten.
If you use too much REVATIO
If you think that you have used too much REVATIO, you may need urgent medical attention.
You should immediately:
phone the Poisons Information Centre
(Australia telephone 13 11 26) for advice, or
contact your doctor, or
go to the Emergency Department at your nearest hospital.
You should do this even if there are no signs of discomfort or poisoning.
As your doctor will supervise how much REVATIO injection you are given, you are unlikely
to have an overdose.
5. What should I know while using REVATIO?
Things you must do
You must stop treatment with REVATIO if you have sudden vision problems including
blurred, decreased or distorted vision, objects appear smaller or further away than
they are, changes to colour vision, loss of eyesight in one or both eyes, experience
loss of hearing
or have an erection that lasts more than 4 hours. Seek medical attention urgently.
If you are about to start taking any new medicines, especially nitrates or riociguat,
tell your doctor and pharmacist that you are being treated with REVATIO.
See "Do not use REVATIO" for a list of common nitrate medications.
Remind any doctor, dentist or pharmacist you visit that you are using REVATIO.
Things you must not do
Do not use drugs containing amyl nitrite (sometimes called "poppers") while you are
on REVATIO.
If you get an angina attack do not take nitrate medicines to relieve the pain but
tell your doctor immediately. Make sure your doctor knows you are being treated with
REVATIO.
Do not take or use REVATIO to treat any other conditions unless your doctor says so.
Do not give REVATIO to anyone else, even if they have the same condition as you.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how REVATIO
affects you.
REVATIO can cause dizziness and effects on vision.
If you experience changes in vision, or dizziness, when on
REVATIO, you should not drive or operate machinery.
Drinking alcohol
Tell your doctor if you drink alcohol.
You may feel lightheaded if you drink alcohol while you are using REVATIO.
Looking after your medicine
REVATIO Tablets:
Store below 30°C.
Keep the tablets in their pack until it is time to take them. If you take your tablets
out of the pack they will not keep as well.
Follow the instructions in the carton on how to take care of your medicine properly.
Store it in a cool dry place away from moisture, heat or sunlight; for example, do
not store it:
in the bathroom or near a sink, or
in the car or on window sills.
Heat and dampness can destroy some medicines.
Keep it where young children cannot reach it.
A locked cupboard at least one-and-a-half metres above the ground is a good place
to store medicines.
REVATIO Solution for Injection will be stored in the pharmacy or in the hospital ward
and is kept below 30°C.
Getting rid of any unwanted medicine
If your doctor tells you to stop taking REVATIO tablets or if the medicine has passed
its expiry date, ask your pharmacist what to do with any left over.
Do not use this medicine after the expiry date.
6. Are there any side effects?
All medicines can have side effects. If you do experience any side effects, most of
them are minor and temporary. However, some side effects may need medical attention.
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions about side effects.
Less serious side effects
Serious side effects
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Serious side effects
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What to do
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Rarely men have lost vision in one or both eyes sometime after taking drugs such as
sildenafil, tadalafil or vardenafil to treat impotence (known as erectile dysfunction).
A small number of people have reported a loss of hearing, which may include a ringing
or other persistent noise in the ears and dizziness, while being treated with REVATIO.
It is not known whether hearing loss is related to REVATIO.
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If you have sudden vision problems, lose sight in one or both eyes or experience changes
in vision such as blurring, decreased or distorted vision, objects appear smaller
or further away than they are, changes to your colour vision, a blue colour to your
vision or a greater awareness of light while on REVATIO, seek medical attention urgently.
If you experience any loss of hearing, tell your doctor as soon as possible.
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Tell your doctor if you notice anything else that may be making you feel unwell.
Other side effects not listed here may occur in some people.
Reporting side effects
After you have received medical advice for any side effects you experience, you can
report side effects to the Therapeutic Goods Administration online at
www.tga.gov.au/reporting-problems . By reporting side effects, you can help provide more information on the safety of
this medicine.
Always make sure you speak to your doctor or pharmacist before you decide to stop
taking any of your medicines.
7. Product details
This medicine is only available with a doctor's prescription.
What REVATIO tablet contains
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Active ingredient
(main ingredient)
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sildenafil (as citrate) equivalent to 20 mg sildenafil per tablet
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Other ingredients
(inactive ingredients)
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microcrystalline cellulose
calcium hydrogen phosphate
croscarmellose sodium
magnesium stearate
OPADRY II complete film coating system OY-LS-28914 White (ID 4323)
Opadry YS-2-19114-A Clear UK (ID 3088)
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Potential allergens
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lactose
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What REVATIO Solution for Injection contains
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Active ingredient
(main ingredient)
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sildenafil (as citrate) equivalent to 10 mg sildenafil per vial
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Other ingredients
(inactive ingredients)
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glucose monohydrate
water for injections
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Do not take this medicine if you are allergic to any of these ingredients.
What REVATIO tablet looks like
REVATIO tablets are white to off-white, round biconvex film coated tablets, debossed
with "RVT 20" on one side and "VLE" on the other side (AUST R 119102).
Available in blister packs containing 90 tablets in each box.
REVATIO Solution for Injection is clear, colourless solution in a glass vial. (AUST
R 171474).
Available in a 20 mL vial in each box.
Who distributes REVATIO
Viatris Pty Ltd
Level 1, 30 The Bond
30-34 Hickson Road
Millers Point NSW 2000
Phone: 1800 274 276
This leaflet was prepared in October 2024.
REVATIO® is a Viatris company trade mark
REVATIO_cmi\Oct24/00